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Business Decision
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First, to compare safety and effectiveness outcomes for canaloplasty and trabeculotomy using the OMNI Surgical System to implantation of the iStent inject in lowering intraocular pressure (IOP) in pseudophakic eyes with open angle glaucoma (OAG), and second, to compare safety and effectiveness outcomes for canaloplasty alone (using the OMNI Surgical System)to implantation of the iStent Inject in lowering IOP in pseudophakic eyes with OAG.
A multicenter, prospective, parallel group study planned to randomize 459 subjects to either 1)canaloplasty + trabeculotomy with the OMNI, 2)canaloplasty alone with the OMNI, or 3)iStent inject in an equal allocation ratio (1:1:1); The study includes baseline and terminal (Month 12) washout. Up to 26 centers in the UK and EU were planned to participate.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ab-interno canaloplasty and trabeculotomy using the OMNI Surgical System | Active Comparator | Sequential canaloplasty (up to 360 degrees) and trabeculotomy (up to 360 degrees) |
|
| Ab-interno canaloplasty (360 degrees) using the OMNI Surgical System | Active Comparator | Canaloplasty alone (up to 360 degrees) |
|
| Ab-interno implantation of iStent inject (2 microstents) | Active Comparator | Implantation of trabecular micro bypass stents as per manufacturer's instructions. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Canaloplasty and trabeculotomy with the OMNI system. | Device | Ab-interno canaloplasty (360 degrees) and up to 360 degrees trabeculotomy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change in Unmedicated DIOP From Baseline at the 12-month Postoperative Examination | Mean change in unmedicated DIOP from baseline at the 12-month postoperative examination is the mean of the difference between the baseline DIOP and the Month 12 DIOP for each subject. Baseline and Month 12 DIOP are measured after appropriate washout of any glaucoma medications. | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
Any of the following prior treatments for glaucoma:
Any other form of glaucoma other than OAG
Concurrent ocular pathology or systemic medical condition which, in the Investigator's judgment, would either place the subject at increased risk of complications, contraindicate surgery, place the subject at risk of significant vision loss during the study period (e.g., wet AMD, corneal edema, Fuch's dystrophy, active intraocular infection or inflammation within 30 days prior to Screening Visit, etc.), or interfere with compliance to elements of the study protocol (e.g., returning to investigator's office for follow-up visits).
Women of childbearing potential if they are currently pregnant or intend to become pregnant during the study period; are breast-feeding; or are not in agreement to use adequate birth control methods to prevent pregnancy throughout the study.
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| Name | Affiliation | Role |
|---|---|---|
| Jaime Dickerson, PhD | Sight Sciences, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| BurgerHospital | Frankfurt | Germany | ||||
| Institut Catala de Retina (ICR) |
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| ID | Title | Description |
|---|---|---|
| FG000 | Canaloplasty Only With the OMNI Surgical System | Subjects randomized to canaloplasty only with the OMNI surgical system |
| FG001 | Canaloplasty + Trabeculotomy With the OMNI Surgical System | Subjects randomized to canaloplasty and trabeculotomy with OMNI |
| FG002 | iStent Inject | Subjects randomized to iStent inject |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
The safety analysis population will contain all subjects for whom either the OMNI (canaloplasty alone), OMNI (canaloplasty AND trabeculotomy), or iStent inject is attempted.
The study was terminated early due to a business decision.
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| ID | Title | Description |
|---|---|---|
| BG000 | OMNI-Canaloplasty Only | All subjects for whom the OMNI (canaloplasty alone) is attempted |
| BG001 | OMNI-canaloplasty + Trabeculotomy | All subjects for whom the OMNI (canaloplasty+trabeculotomy) is attempted |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mean Change in Unmedicated DIOP From Baseline at the 12-month Postoperative Examination | Mean change in unmedicated DIOP from baseline at the 12-month postoperative examination is the mean of the difference between the baseline DIOP and the Month 12 DIOP for each subject. Baseline and Month 12 DIOP are measured after appropriate washout of any glaucoma medications. | Results are not presented for this outcome as no subjects had reached the primary endpoint of Month 12 at the time of study termination. | Posted | 12 months |
|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | OMNI-canaloplasty Alone | The safety analysis population will contain all subjects for whom the OMNI (canaloplasty alone) is attempted |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| IOP elevation | Eye disorders | Non-systematic Assessment | IOP elevation. Both AE occurred in subject study eye; Both subjects randomized to canaloplasty |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| VP, Medical and Clinical Affairs | Sight Sciences, Inc. | 877-266-1144 | jdickerson@sightsciences.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 14, 2021 | Aug 11, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D005902 | Glaucoma, Open-Angle |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D014130 | Trabeculectomy |
| ID | Term |
|---|---|
| D018463 | Filtering Surgery |
| D013508 | Ophthalmologic Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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| iStent inject | Device | Ab-interno implantation of iStent inject (2 microstents) |
|
| Canaloplasty | Device | Ab-interno canaloplasty (360 degrees) using the OMNI |
|
| Barcelona |
| 08022 |
| Spain |
| Universidad Complutense de Madrid | Valencia | 46026 | Spain |
| Paseo Isabel la Católica 1-3. Edificio general Hospital Miguel Servet. Planta calle | Zaragoza | 50009 | Spain |
| Manchester Royal Eye Hospital | Manchester | M13 | United Kingdom |
| BG002 | iStent Inject | All subjects for whom the iStent inject is attempted |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| Diurnal IOP (DIOP) | Diurnal IOP is the mean of IOP measurements taken at 9AM, noon, and 4PM using Goldmann tonometry. The baseline DIOP is assessed after subjects have gone through a glaucoma medication washout. | Mean | Standard Deviation | mm Hg |
|
Subjects randomized to canaloplasty + trabeculotomy with the OMNI surgical system
| OG002 | iStent Inject | Subjects randomized to iStent inject |
|
| 0 |
| 5 |
| 0 |
| 5 |
| 3 |
| 5 |
| EG001 | OMNI-canaloplasty + Trabeculotomy | The safety analysis population will contain all subjects for whom the OMNI (canaloplasty+trabeculotomy) is attempted | 0 | 1 | 0 | 1 | 1 | 1 |
| EG002 | iStent Inject | The safety analysis population will contain all subjects for whom the iStent injectis attempted | 0 | 4 | 0 | 4 | 0 | 4 |
|
| Anterior chamber inflammation | Eye disorders | Non-systematic Assessment | Anterior chamber inflammation - Occurred in study eye; subject randomized to canaloplasty. |
|
| Allergic conjunctivitis | Eye disorders | Non-systematic Assessment | Allergic conjunctivitis (non-infectious) - occurred in study eye. Subject randomized to canaloplasty. |
|
| Tendinitis | General disorders | Non-systematic Assessment | Tendinitis-right tibialis,anterior, n (%). Subject randomized to canaloplasty. |
|
| COVID-19 infection | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | COVID-19. One subject in canaloplasty arm, one subject in canaloplasty+trabeculotomy arm. |
|
After Sponsor's publication of trial results, the Institution and Principal Investigator may publish the results of the Study generated by the Institution, subject to the obligations of the CTA, and prior approval of Sponsor in writing. The Institution shall furnish Sponsor with a written copy of any proposed publication or disclosure at least 60 days prior to submission for publication or disclosure. Sponsor may request changes or other measures to ensure the information is fairly stated.